Alprazolam
- Product NDC
- 45865-653
- 11-digit product format
- 458650653
- Labeler code
- 45865
- Product ID
- 45865-653_72b94ebe-ba7f-62fd-e053-2991aa0a490c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA090871
- Marketing category
- ANDA
- Marketing start
- 2011-06-07
- Marketing end
- 0000-00-00
- Substance
- ALPRAZOLAM
- Active strength
- 1 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-653-15 | Alprazolam | 15 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 15 | | 5 |
| 45865-653-30 | Alprazolam | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 5 |
| 45865-653-60 | Alprazolam | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 2 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 2 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 2 | |
| HYPROMELLOSE 2208 (4000 MPA.S) | INACTIVE INGREDIENT | 39J80LT57T | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-653 | ALPRAZOLAM TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS] | 5 | Legacy NDC, 3 package rows | 20180806_1b68bd67-65cf-4c64-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 45865-653-15 | 45865065315 | 15 in 1 BOTTLE | Historical |
| 45865-653-30 | 45865065330 | 30 in 1 BOTTLE | Historical |
| 45865-653-60 | 45865065360 | 60 in 1 BOTTLE | Historical |